European Drug Shortage Monitoring Platform Fully Operational

The European Medicines Agency (EMA) announced on Jan. 29, 2025 that the European Shortages Monitoring Platform (ESMP) now has full functionality (1). ESMP was created so that marketing authorization holders (MAHs) and national competent authorities (NCAs) can directly report information about the supply, demand, and availability of authorized medicines, especially during crises situations. The information can then be used by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). EMA launched the platform in November 2024 (2) with core functionalities available at the time. On Feb. 2, 2025, use of ESMP becomes mandatory for MAHs and NCAs.

ESMP features monitoring and management of critical medicines during public health emergencies and is a requirement of EMA’s mandate to enhance monitoring of drug shortages and prepare for critical situations in the European Union and the European Economic Area (EU/EEA). The platform features harmonized reporting standards to enhance usability of data to allow the EU/EEA to quickly coordinate actions to mitigate drug shortages.

Training on the platform is available through webinars and information provided on EMA’s website. EMA’s Medicine Shortages Single Point of Contact (SPOC) Working Party provides additional information in its webpage (3). Information about drug shortages in the EU is available on EMA’s shortages catalogue and national shortages catalogues (4).

“The release of the ESMP is a major milestone in the effort to tackle medicine shortages and ensure that medicines are available to patients when and where they need them most,” the agency stated in the November 2024 press release (2). “It will centralize and automate data collection on medicine shortages, giving regulatory authorities access to real-time, comprehensive information to improve the prevention, monitoring, and management of medicine shortages across the [EU and EEA].”

The industry often experiences drug shortages due to quality control issues, natural disasters, and periods of high demand. According to FDA in the United States, the leading causes of shortages are manufacturing quality issues, followed by delays in receiving materials from suppliers (5). Drug companies in the US have been required since 2012 to notify FDA about changes in product production of certain medicines to prevent shortages. And in 2024, FDA’s ability to identify and mitigate such shortages was enhanced by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which says that manufacturers must notify the agency of a permanent discontinuation of these crucial products, interruption of manufacture of these products, permanent discontinue of an API used in these products, and interruption of APIs used in these products (5).

References

1. EMA. European Shortages Monitoring Platform fully operational for monitoring of shortages in the EU. Press Release. Jan. 29, 2025.
2. EMA. European Shortages Monitoring Platform Enables Better Monitoring of Shortages in the EU. Press Release. Nov. 28, 2024.
3. EMA. Medicine Shortages Single Point of Contact (SPOC) Working Party. https://www.ema.europa.eu/en/committees/working-parties-other-groups/medicines-shortages-single-point-contact-spoc-working-party (accessed Jan. 29, 2025).
4. EMA. Public Information on Medicine Shortages. Ema.europa.eu (accessed Jan. 29, 2025). https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/public-information-medicine-shortages
5. FDA. Frequently Asked Questions about Drug Shortages. FDA.gov, Dec. 18, 2024 (accessed Jan. 29, 2025). https://www.fda.gov/drugs/drug-shortages/frequently-asked-questions-about-drug-shortages